Amgen Inc. has agreed to a $71 million settlement of claims that the pharmaceutical giant marketed two of its drugs for uses not approved by the U.S. Food and Drug Administration, according to media reports.
The Thousand Oaks company was alleged to have violated consumer protection laws in 48 states and the District of Columbia, according to a story published by Reuters.
Specifically, Amgen is said to have promoted its plaque psoriasis drug Enbrel and anemia drug Aranesp for conditions not approved by the FDA. The company is also alleged to have marketed Aranesp for longer dosing frequencies than the FDA had approved, according to Reuters.
Enbrel is used to treat moderate to severe plaque psoriasis but Amgen had marketed it for mild cases of that condition.
The Enbrel-related conduct occurred during 2004 to 2011 while the Aranesp-related conduct happened from 2002 to 2007, according to Amgen.
The $71 million will be divided up between the states alleging the complaint. Oregon's Attorney General Ellen Rosenblum was the lead plaintiff in the action filed in Multnomah County.
Amgen released a statement on Tuesday saying it was pleased to resolve the states’ claims.
“Amgen is pleased to have this matter resolved and remains committed to fulfilling its mission to serve patients. Amgen has a strong compliance program, and our management is dedicated to fostering a culture of doing the right thing at Amgen in full compliance with the law,” the statement said.
The settlement is a follow up to a case from two-and-a-half years ago.
In December 2012, Amgen accepted criminal liability and agreed to pay $762 million for illegally marketing Aranesp by misbranding the drug.
In that case, in U.S. District Court in Brooklyn, Amgen was recommending higher doses and frequency of use than the drug was labeled for by the FDA. It was also urging use of the drug in cancer patients with anemia who were not undergoing chemotherapy, a practice later proven to be dangerous.
Shares closed down $2.07, or just over 1 percent, to $167.72 on the Nasdaq.